Cardiovascular Clinical Trials: Putting the Evidence into Practice PDF
Preview Cardiovascular Clinical Trials: Putting the Evidence into Practice
Cardiovascular Clinical Trials Cardiovascular Clinical Trials PUTTING THE EVIDENCE INTO PRACTICE Edited by Marcus D. Flather, MBBS, FRCP Professor of Medicine and Clinical Trials University of East Anglia and Norfolk and Norwich University Hospital Norwich, UK Deepak L. Bhatt, MD, MPH, FACC, FAHA, FESC Chief of Cardiology, VA Boston Healthcare System; Director, Integrated Interventional Cardiovascular Program, Brigham and Women’s Hospital & VA Boston Healthcare System; Professor of Medicine, Harvard Medical School; Senior Investigator, TIMI Study Group Boston, MA, USA Tobias Geisler, MD Associate Professor of Medicine Consultant, Cardiology University Hospital Tübingen Tübingen Medical School Tübingen, Germany A John Wiley & Sons, Ltd., Publication This edition fi rst published 2013, © 2013 by Blackwell Publishing. BMJ Books is an imprint of BMJ Publishing Group Limited, used under licence by Blackwell Publishing which was acquired by John Wiley & Sons in February 2007. 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No warranty may be created or extended by any promotional statements for this work. Neither the publisher nor the author shall be liable for any damages arising herefrom. Library of Congress Cataloging-in-Publication Data Cardiovascular clinical trials : putting the evidence into practice / edited by Marcus D. Flather, Deepak L. Bhatt, Tobias Geisler. p. ; cm. Includes bibliographical references and index. ISBN 978-1-4051-6215-9 (pbk. : alk. paper) I. Flather, M. II. Bhatt, Deepak L. III. Geisler, Tobias. [DNLM: 1. Cardiovascular Diseases–prevention & control. 2. Clinical Trials as Topic. WG 120] 616.100724–dc23 2012009758 A catalogue record for this book is available from the British Library. Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic books. Cover images: iStock © Christian Jasiuk and Anthony A. Bavry et al. Eur Heart J (2008) 29(24): 2989–3001 by permission of Oxford University Press Cover design by Grounded Design Set in 9.5 on 12 pt Palatino by Toppan Best-set Premedia Limited MDF: To my family Ruth, Hannah, and Alex, and the team at the Royal Brompton Clinical Trials and Evaluation Unit. DLB: To my wife Shanthala and my sons Vinayak, Arjun, Ram, and Raj, with the deepest gratitude for allowing me to pursue my passion for clinical trials. TG: To my wife Katja and my daughters Marlene and Mathilde for persevering with me through all endeavors and giving me liberty to develop my dedication to clinical research. Contents List of contributors, viii Preface, x List of abbreviations, xi 1 Introduction to randomized clinical trials in cardiovascular disease, 1 Tobias Geisler, Marcus D. Flather, Deepak L. Bhatt, and Ralph B. D’Agostino, Sr 2 Publishing results of clinical trials and reviewing papers for publication, 44 Tobias Geisler and Marcus D. Flather 3 Management of chronic coronary artery disease, 60 Sabu Thomas and William E. Boden 4 Acute coronary syndromes (ST elevation and non-ST elevation), 86 Tobias Geisler,Deepak L. Bhatt, and Marcus D. Flather 5 Heart failure, 117 Christopher M. O’Connor and Wendy Gattis Stough 6 Atrial fi brillation, 143 Chee W. Khoo and Gregory Y.H. Lip 7 Electrophysiology and pacing, 174 Irina Suman-Horduna and Sabine Ernst 8 Percutaneous coronary intervention, 205 Dharam J. Kumbhani and Deepak L. Bhatt 9 Randomized controlled trials in cardiac surgery: is there any alternative?, 243 Thanos Athanasiou, Amir Sepehripour, and John Pepper 10 Adult congenital heart disease, 274 Cary Ward, J. Kevin Harrison, and Thomas M. Bashore 11 Cardiac imaging, 296 Aiden Abidovand Daniel S. Berman 12 Prevention of cardiovascular disease, 345 Alice J. Owen and Christopher M. Reid Index, 378 vii List of contributors Aiden Abidov, MD, PhD, FACC, FAHA Ralph B. D’ Agostino, Sr Associated Professor of Medicine and Radiology Department of Mathematics The University of Arizona College of Medicine Boston University Tucson, AZ, USA Boston, MA, USA Thanos Athanasiou, MD, PhD, FETCS, Sabine Ernst, MD, PhD, FESC FRCS National Heart and Lung Institute Cardiothoracic Surgeon Imperial College; Hammersmith Hospital Royal Brompton and Harefi eld Hospital Imperial College London, UK London, UK Marcus D. Flather, MBBS, FRCP Thomas M. Bashore, MD Professor of Medicine and Clinical Trials Professor of Medicine University of East Anglia and Norfolk and Division of Cardiology Norwich University Hospital Duke University Medical Center Norwich, UK Durham, NC, USA Tobias Geisler, MD Daniel S. Berman, MD, FACC, FAHA, Associate Professor of Medicine FSCCT Consultant, Cardiology Professor of Medicine University Hospital T ü bingen Department of Imaging and Department of T ü bingen Medical School Medicine T ü bingen, Germany Cedars - Sinai Medical Center; Department of Medicine J. Kevin Harrison, MD David Geffen School of Medicine, UCLA Professor of Medicine Los Angeles, CA, USA Division of Cardiology Duke University Medical Center Deepak L. Bhatt, MD, MPH, FACC, Durham, NC, USA FAHA, FESC Chief of Cardiology, VA Boston Healthcare Chee W. Khoo, MRCP System; Research Fellow Director, Integrated Interventional Cardiovascular University of Birmingham Centre for Program, Brigham and Women ’ s Hospital & VA Cardiovascular Sciences Boston Healthcare System; City Hospital Professor of Medicine Birmingham, UK Harvard Medical School; Senior Investigator, TIMI Study Group Dharam J. Kumbhani, MD, SM Boston, MA, USA Division of Cardiovascular Medicine Brigham and Women ’ s Hospital William E. Boden, MD, FACC, FAHA Harvard Medical School Professor of Medicine, Albany Medical College; Boston, MA, USA Chief of Medicine Samuel S. Stratton VA Medical Center; Gregory Y.H. Lip, MD, FRCP Vice-Chairman, Department of Medicine, Professor of Cardiovascular Medicine Albany Medical Center University of Birmingham Centre for Albany, NY, USA Cardiovascular Sciences City Hospital Birmingham, UK viii List of contributors ix Christopher M. O’ Connor, MD Wendy Gattis Stough, PharmD Professor of Medicine and Director Assistant Consulting Professor Duke Heart Center Duke University Medical Center Duke University Medical Center Durham, NC; Durham, NC, USA Associate Professor of Clinical Research Campbell University School of Pharmacy Alice J. Owen, PhD Buies Creek, NC, USA Department of Epidemiology & Preventive Medicine Irina Suman-Horduna, MD, MSc Monash University National Heart and Lung Institute Melbourne, VIC, Australia Imperial College; Royal Brompton and Harefi eld Hospital John Pepper, MA, MChir, FRCS London, UK Cardiothoracic Surgeon Royal Brompton Hospital Sabu Thomas, MD, FACC, FRCPC London, UK Assistant Professor Division of Cardiology Christopher M. Reid, PhD University of Rochester School of Medicine Professor of Cardiovascular Epidemiology Rochester, NY, USA Department of Epidemiology & Preventive Medicine Cary Ward, MD Monash University Assistant Professor Melbourne, VIC, Australia Division of Cardiology Duke University Medical Center Amir Sepehripour, BSc, MBBS, MRCS Durham, NC, USA Specialist Registrar Cardiothoracic Surgery Imperial College London, UK Preface Randomized controlled trials (RCTs) represent the highest standard to test whether a therapeutic intervention is safe and effective. RCTs are of pivotal importance for regulatory authorities, healthcare providers, and medical asso- ciations for the introduction of new treatments in clinical practice. Cardiovas- cular medicine is a rapidly growing fi eld with enormous innovation in the last decade. RCTs in cardiovascular medicine are usually performed under enormous time pressure to keep up with the dynamic advances in this fi eld, but they need to comply with standards of quality. This apparent confl ict between timely completion and reporting of RCTs, and the growing demands on good clinical research practice, creates a clear challenge to investigators and sponsors of clinical research. Additionally, as healthcare steadily improves, it is more diffi cult to show superiority of new treatments compared with established therapies; larger patient cohorts are often required to show that a new treatment is superior to its comparator. Despite these barriers, a myriad of landmark RCTs have been conducted in the last few years, leading to a major change in the treatment landscape and contributing to current guide- lines in the cardiovascular fi eld. This book provides a unique overview of quality standards for clinical trials and guides the reader through methodological design, results, and interpreta- tion of RCTs, using examples of recent important trials in major fi elds of cardiovascular medicine. Each of the major cardiovascular specialties is covered and modern concepts of diagnosis and management are described. This book is intended for clinicians who want an update on current develop- ments in clinical trials in cardiovascular medicine, for those who plan to conduct a clinical trial, and last but not least, to assist in translating the evi- dence into practice. We would like to thank all the chapter authors for sharing their expert insights in this book. We would also like to thank Helen Whyte of the Royal Brompton Hospital for administrative support, Mary Banks (Wiley - Blackwell) for encouraging us to pursue the book, and Jon Peacock (Wiley - Blackwell) for editorial support in completing the manuscript. Marcus D. Flather, Deepak L. Bhatt and Tobias Geisler x List of abbreviations A - HeFT African American Heart Failure Trial A4 Atrial fi brillation ablation versus antiarrhythmic drugs study ABSORB Clinical Evaluation of the BVS everolimus eluting stent system ACCOMPLISH Avoiding Cardiovascular Events through Combination Therapy in Patients Living with Systolic Hypertension ACCURACY Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography ACME Angioplasty Compared to Medicine ACTIVE - A Clopidogrel plus aspirin vs. aspirin alone in atrial fi brillation ACTIVE - W Clopidogrel plus aspirin vs. oral anticoagulants in atrial fi brillation ACUITY Bivalirudin vs. heparin and GP IIb/IIIa inhibitors in acute coronary syndromes ACUITY - timing trial Routine upfront initiation vs. GP IIb/IIIa inhibitors in acute coronary syndromes ADHERE registry Acute Decompensated Heart Failure National Registry AF - CHF Rate control vs. rhythm control in atrial fi brillation and congestive heart failure AFASAK Atrial Fibrillation, Aspirin, Anticoagulation AFFIRM Atrial Fibrillation Follow - Up Investigation of Rhythm Management AIM - HIGH Atherothrombosis Intervention in Metabolic syndrome with low HDL/high triglycerides: impact on Global Health outcomes AIMI AngioJet Rheolytic Thrombectomy In Patients Undergoing Primary Angioplasty for Acute Myocardial Infarction ALLHAT Antihypertensive and Lipid - Lowering Treatment to prevent Heart Attack Trial AMEthyst Assessment of the Medtronic AVE Interceptor Saphenous Vein Graft Filter System AMIGO Atherectomy before Multi - link Improves lumen Gain and clinical Outcomes xi xii List of abbreviations AMRO Amsterdam - Rotterdam study APAF A randomized trial of circumferential pulmonary vein ablation vs. antiarrhythmic drug therapy in paroxysmal atrial fi brillation APPRAISE - 2 Apixaban for Prevention of Acute Ischemic Events 2 ARISTOTLE Apixaban vs. Warfarin in Patients with Atrial Fibrillation ARTIST Angioplasty versus Rotational Atherectomy for Treatment of Diffuse In - stent Restenosis Trial ARTS Arterial Revascularization Therapies Study ASCOT - BPLA Anglo - Scandinavian Cardiac Outcomes Trial – Blood Pressure Lowering ASPARAGUS Comparison of thrombectomy to percutaneous coronary intervention alone for myocardial infarction ASPREE Aspirin in Reducing Events in the Elderly ATLAS - 1 - TIMI 46 Anti - Xa Therapy to Lower cardiovascular events in Addition to standard therapy in Subjects with Acute Coronary Syndrome – Thrombolysis in Myocardial Infarction 46 ATLAS - TIMI 51 Rivaroxaban in addition to standard care for acute coronary syndromes AVERROES Apixaban Versus Acetylsalicylic acid (ASA) to Prevent Strokes AVERT Atorvastatin VErsus Revascularization Treatment AVID Antiarrhythmic Versus Implantable Defi brillators AWESOME Angina With Extremely Serious Operative Mortality/ Evaluation BAATAF Boston Area Anticoagulation Trial for Atrial Fibrillation BAFTA Birmingham Atrial Fibrillation Treatment of the Aged BARI Bypass Angioplasty Revascularization Investigation BARI - 2D Bypass Angioplasty Revascularization Investigation 2D BASKET Basel Stent Kosten Effektivitats Trial BEAUTIFUL Morbidity - Mortality Evaluation of the If Inhibitor Ivabradine in Patients With Coronary Artery Disease and Left Ventricular Dysfunction BENESTENT BElgian NEtherlands STENT BREATHE - 5 Bosentan Therapy in Patients With Eisenmenger Syndrome CABANA Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation CABRI Coronary Artery versus Bypass Revascularization Investigation
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